A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 months to < 24 months
This study is investigating two new vaccines, mRNA-1345 and mRNA-1365, focusing on babies between 5 and 23 months old. The main aim is to understand how safe these vaccines are and if they cause any side effects. Researchers will also check if the vaccines help the babies' bodies create an immune response to fight off chest infections, particularly those caused by common viruses like RSV. Some babies will receive one of the new vaccines, some an existing vaccine for meningitis, and others a salt-water solution (placebo) for comparison. This helps scientists see if any effects are truly due to the new vaccines. The study will carefully monitor the babies for any reactions and measure how their immune system responds.
At a glance
What is this study about?
Imagine your little one gets a bad cough or chest infection that makes it hard to breathe. These infections can be serious for babies and sometimes lead to a stay in the hospital. Scientists are working on new vaccines to help protect babies from these types of infections, especially those caused by viruses like RSV (Respiratory Syncytial Virus).
This particular study is a very early stage trial, called a 'Phase 1' study. This means it's primarily focused on safety. Researchers want to make sure the experimental vaccines, named mRNA-1345 and mRNA-1365, don't cause any serious problems for very young children. They will also look at how tolerable the vaccines are, meaning how well babies handle them and if they have common side effects like a sore arm or a fever.
Another important part of this study is to see if these new vaccines can help a baby's body build protection. They will check to see if the vaccines encourage the immune system to make 'antibodies' – special proteins that can fight off viruses. By understanding both the safety and early immune response, doctors can decide if these vaccines should be studied further in larger groups of children.
Key takeaways
- This study is testing the safety and early immune response of new vaccines (mRNA-1345 and mRNA-1365) in babies.
- It's for babies aged 5 months to just under 2 years old.
- The vaccines aim to protect against serious chest infections, like RSV.
- Some babies will receive a new vaccine, some an existing vaccine, and some a placebo.
- Close monitoring for side effects and immune response will be a key part of the study.
- Your decision to participate or withdraw will not affect your baby's regular medical care.
Who may be eligible?
This study is for babies in a specific age group. To be considered, your baby would need to be between 5 months old and just under 2 years old (so, from 5 months up to 23 months old). The study is open to both baby boys and baby girls.
Scientists looking for participants often have other health requirements to make sure the study is as safe as possible and that the results are clear. For example, they might look at your baby's general health, any existing medical conditions, or medications they might be taking. These details help ensure the study is suitable for your child.
- Is my baby between 5 and 23 months old?
- Is my baby generally healthy?
- Am I comfortable with my baby receiving an experimental vaccine or a placebo?
- Can I commit to multiple clinic visits and close monitoring for my baby?
- Do I understand and accept the potential risks and benefits?
- Am I willing to provide detailed information about my baby's health?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If your baby takes part in this study, they would receive either one of the new vaccines (mRNA-1345 or mRNA-1365), an existing meningitis vaccine, or a saline solution (a placebo, which looks just like the real vaccine but has no active ingredients). This is usually given as an injection. The study doctors and nurses will closely monitor your baby for any reactions or side effects for a period afterwards. This might involve keeping a diary of how your baby is feeling over the next week or so.
There will be several visits to the clinic for check-ups and further assessments. These visits will allow the medical team to continue monitoring your baby's health, check for any illnesses, and take blood samples to see how their immune system is responding to the vaccine. The entire study, including all follow-up, could last for many months to ensure all safety and immune response data is collected.
Potential risks and benefits
Locations (3)
- —Spain
- —Latvia
- —Poland
Common questions
What is RSV?
RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms, but for babies and young children, it can lead to more serious breathing problems like bronchiolitis or pneumonia.
What does 'Phase 1 study' mean?
A Phase 1 study is the first step in testing a new treatment or vaccine in people. It mainly focuses on checking if it's safe and what the right dosage might be, rather than how well it works.
Will my baby get a real vaccine or a placebo?
Some babies in the study will get one of the new vaccines, some an existing vaccine, and some a placebo (a 'dummy' injection of salt water). Who gets what is decided randomly, like flipping a coin, but neither you nor the study team will know during the study which one your baby received.
What are 'antibodies'?
Antibodies are special proteins made by your body's immune system. They recognise and fight off harmful invaders like viruses and bacteria, helping to protect you from illness.
Can I take my baby out of the study if I change my mind?
Yes, you are completely free to withdraw your baby from the study at any time, for any reason, and it will not affect the medical care your baby receives in the future.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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